C50 C79
Conditions
Interventions
Group 1: 250 patients with hormone-receptor (HR)-positive HER2-negative metastatic breast cancer, who have progress on or after CDK4/6i and AI based therapy should be included in the study. Blood samp
Sponsors
Universität Heidelberg
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with HR+/HER2- metastastic breast cancer ? progressing on or after a CDK4/6i in combination with an AI ? = 18 years of age ? Signed written informed consent ? willing to provide a plasma sample for testing
Exclusion criteria
Exclusion criteria: - Missing written consent ? Any medical condition that prevents consent ? No prior CDK4/6 inhibitors ? No prior AI treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - to define the mutational landscape, focused on the prevalence of ESR1 mutations and PIK3CA/AKT alterations in ctDNA, stratified by prior CDK4/6i treatment in a real-world cohort of patients - to define the prevalence of co-existing PIK3CA/AKT mutations and furtherresistance variants - to define the value of using a ctDNA assay with respect to the identification of additional druggable genomic alterations | — |
Secondary
| Measure | Time frame |
|---|---|
| Turnaround time of testing (TAT) ? PFS on CDK4/6i prior to entering the study stratified by o ESR1& PIK3CA/AKT ? Treatment patterns prior to entering the study | — |
Countries
Germany
Contacts
Public ContactFrederik Marmé
Medizinische Fakultät Mannheim der Universität Heidelberg
Outcome results
None listed